Suture based tissue repair

ABSTRACT

The present invention provides an apparatus for suture-based tissue repair, preferably for the annulus of a spinal disc, that includes a suture loop preferably pre-tied with a sliding knot, a clasp-type component that captures the ends of the suture loop, and an optional plug member that fills the tissue defect. Also disclosed is a method that places the suture loop in a full-thickness stitch encircling the tissue defect, secures the ends of the suture loop to the clasp, and cinches the suture loop to approximate the tissue without the need to tie knots. Also disclosed is a suture passer that enables a suture strand or loop to be passed through the tissue wall, captured, and retrieved. The suture passer may optionally incorporate a clasp in such an arrangement that enables a suture loop passed through the tissue wall to be captured directly by the clasp.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the National Stage of International Application No.PCT/US2009/046624, filed Jun. 8, 2009, which claims the benefit of U.S.Provisional Application No. 61/059,584, filed Jun. 6, 2008, thedisclosures of which are incorporated herein by reference in theirentireties for all purposes.

BACKGROUND OF THE INVENTION

Sciatica, or radicular leg pain, is suffered by millions of Americans.One common cause of sciatica is ruptured or herniated discs of the spinefor example, in the lumbar area. That is, when the outer wall of anintervertebral disc (i.e., the annulus fibrosis) becomes weakened, itmay tear allowing the soft inner part of the disc (i.e., the nucleuspulposus) to push its way out. Once the nucleus pulposus extends outpast the regular margin of the annulus fibrosis, the nucleus pulposuscan press against very sensitive nerve tissue in the spine resulting inradicular pain. One treatment for relieving radiculopathy is adiscectomy. A discectomy is a surgical procedure performed to remove atleast a part of the damaged disc to relieve the pressure on the nervetissue and alleviate the pain. The surgery generally involves a smallincision in the skin over the spine, removal of some ligament and bonematerial to access the disc and the removal of some of the discmaterial, e.g., removing herniated nucleus pulposus to achieve neuraldecompression. Currently, standard discectomy techniques do not repairthe defect or incision in the annulus fibrosis. As a result, theremaining nucleus pulposus may extend or push its way out of the openingor damaged annulus fibrosis post-operatively. Alternatively the surgeonmay elect to perform extensive debulking, in which most of the remainingnucleus material is removed in addition to the herniated portion tominimize the risk of post-operative reherniation, but this increases therisk of post-operative disc height collapse and subsequent progressionto increased lower back pain.

Thus there remains a need to provide a tissue repair system and methodand more specifically an annulus fibrosis repair system and method tosolve the challenges present in current discectomy procedures and thepost-operative complications associated therewith.

BRIEF SUMMARY OF THE INVENTION

The present invention provides an apparatus for suture-based tissuerepair, including repairing a defect or opening in the annulus fibrosisof a spinal disc, that comprises a suture loop preferably pre-tied witha sliding knot, and a clasp-type component that captures the ends of thesuture loop. An optional plug member that fills the opening in theannulus fibrosis may also be included. Also disclosed is a method thatplaces the suture loop in a full-thickness stitch encircling the annulusdefect, secures the ends of the suture loop to the clasp, and cinchesthe suture loop to approximate the annular tissue without the need totie knots. Also disclosed is a suture passer that enables a suturestrand or loop to be passed through the annulus wall, captured, andretrieved. The suture passer may optionally incorporate a clasp in suchan arrangement that enables a suture loop passed through the annuluswall to be captured directly by the clasp.

In one embodiment a system for spinal disc annulus repair is providedwhich comprises a strand of suture and a clasp device. The suturepreferably has at least one loop and at least one sliding knot, and theclasp device preferably has at least one eyelet. The eyelet may comprisea closed ring, a C-shape, a U-shape, an S-shape, an O-shape, a coilshape, or other shape having an opening to permit a suture to pass intothe eyelet. The system may further comprise a suture passer andretriever instrument that may include a needle having a receptacle forreceiving the suture.

In another embodiment a further system for repairing a defect in theannulus of a spinal disc is provided that may comprise a strand ofsuture and a clasp device having an eyelet for securing the suture. Thesuture may have at least one loop having two ends and a sliding knot,and the eyelet of the clasp device may be configured for securing theends of the suture loop, wherein the suture and clasp device areconfigured and arranged in combination to surround the annulus defectand approximate the defect with the two ends of the loop extending inopposite directions from the clasp device. The suture and clasp devicepreferably are in series in forming a loop surrounding the defect of theannulus fibrosis. The system may further comprise a suture passer andretriever instrument. The suture passer may include a needle releasablyattached to the suture and preferably for passing the suture through thedisc annulus. The retriever instrument is preferably configured tocooperate and preferably work in association with the needle.

The suture passer and retriever instrument may further comprise a boomarm for capturing the suture. The suture passer and retriever instrumentmay be releasably coupleable to the clasp device. The system may furthercomprise a plug member for filling and sealing the annulus defect. Thesystem may further comprise a plurality of barbs, one barb connected toeach of the ends of the suture loop, and wherein the clasp device has aplurality of eyelets, each eyelet connectable to the barbs, wherein theeyelet is expandable and at least a portion of the barb is configured topass through the eyelet. Alternatively or additionally, the suturepasser and retriever instrument may comprise a wire loop for capturingthe suture.

The clasp device may include a two piece clip, the first piececonnectable to a first end of the suture loop, a second piece of theclip connectable to a second end of the suture loop, and the first piececoupleable to the second piece. The clasp device may have two hookshaving open slots to receive the suture, the hooks being resilientlyflexible to collapse to a smaller size and expand to a larger size. Thesuture passer and retriever instrument may further comprise two needles,each needle connectable to an end of the suture loop and beingindependently moveable, the clasp device releasably connectable to thesuture passer and retriever instrument, the clasp device having anopening for receiving the suture.

In another embodiment, a method of repairing a defect in an annulus of aspinal disc is provided, the method comprising the steps of: (1)providing a suture having at least one loop and a sliding knot; (2)providing a clasp device for capturing the ends of the suture loop; (3)providing a passing device for attaching to the suture loops, thepassing device for passing the suture through a wall of the annulus; (4)attaching a first end of the suture loop to the passing device; (5)inserting the passing device with the suture loop end through the discannulus wall; (6) inserting the second end of the suture loop throughthe disc annulus wall; (7) connecting the first end and second end ofthe suture loop to the clasp device while the suture loop ends and claspdevice are outside the spinal disc; (8) inserting the clasp devicethrough the annulus defect so that the suture loop and clasp device forma continuous loop around the annulus defect; and (9) tightening thesuture to tension the suture loop to close the defect, wherein the claspdevice and suture loop are in series with each other and both the sutureand clasp device approximate and draw the defect closed.

The method may further include the passing device comprising a needleand the further step of releasably attaching the needle to the sutureloop. The method may further include the steps of coupling the passingdevice to the clasp device, and releasing the clasp device from thepassing device. The method may further comprise the steps of: (1)inserting the first end of the suture loop through the annulus wall fromthe outside to the inside of the disc; (2) retrieving the first end ofthe suture loop through the defect in the annulus so that the first endof the suture loop is outside the disc space; (3) inserting the secondend of the suture loop from the outside to the inside of the disc; and(4) retrieving the second end of the suture loop through the defect inthe annulus so that the second end of the suture loop is outside thedisc space. The method may further comprise using a multi-piececonnectable clip, and connecting a first piece of the multi-piece clipto a second piece of the multi-piece clip. The method may furthercomprise: connecting a first end of the suture loop to the first pieceof the multi-piece clip; and connecting a second end of the suture loopto the second piece of the multi-piece clip.

It should be understood, however, that the system, kit and method of useis not limited to the precise arrangements, structures, features,embodiments, aspects and instrumentalities shown, and that thearrangements, structures, and features disclosed herein can be usedsingularly or in combination with other arrangements, structures,features, aspects and instrumentalities.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe preferred embodiments of the application, will be better understoodwhen read in conjunction with the appended drawings. For the purposes ofillustrating the system, device and method of the present application,there is shown in the drawings preferred tissue repair systems,embodiments and techniques. It should be understood, however, that theapplication is not limited to the precise arrangements, structures,features, embodiments, aspects and instrumentalities shown, and that thearrangements, structures, features, disclosed herein can be usedsingularly or in combination with other arrangements, structures,features, aspects and instrumentalities. In the drawings:

FIG. 1 illustrates an embodiment of a preformed suture loop that may beused in the present invention;

FIG. 2 illustrates a perspective view of an open ring suture clasp inaccordance with the present invention.

FIG. 3 illustrates a perspective view of a closed ring suture clasp inaccordance with the present invention.

FIG. 4 illustrates a double eyelet suture clasp in accordance with thepresent invention, and an embodiment of an insertion instrument.

FIG. 5A-E illustrates a tissue repair system and method in accordancewith the present invention.

FIG. 6 illustrates an alternate tissue repair system and method inaccordance with the present invention.

FIG. 7 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 6.

FIG. 8 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 6.

FIG. 9 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 6.

FIG. 10 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 6.

FIG. 11 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 6.

FIG. 12 illustrates another alternate tissue repair system and method inaccordance with the present invention.

FIG. 13 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 12.

FIG. 14 illustrates an additional method step used with the alternatetissue repair system and method shown in FIG. 12.

FIG. 15 illustrates an additional, and preferably last, method step usedwith the alternate tissue repair system and method shown in FIG. 12.

FIG. 16 illustrates yet another alternate tissue repair system andmethod in accordance with the present invention.

FIG. 17A-B illustrates a tissue repair system and method that includes apair of barbs, in accordance with the present invention.

FIG. 18 illustrates an alternate embodiment of a suture passinginstrument in accordance with the present invention.

FIG. 19A-F illustrates an alternative tissue repair system and method inaccordance with the present invention;

FIG. 20 illustrates an alternative tissue repair system in accordancewith the present invention;

FIG. 21 illustrates an alternative tissue repair system in accordancewith the present invention;

FIGS. 22A-K illustrates an alternative method for tissue repair usingthe systems of FIGS. 20 and 21.

FIG. 23 illustrates a tissue repair system and method that includes aclasp with multiple suture loops, in accordance with the presentinvention.

FIG. 24A-B illustrates a tissue repair system and method that includes aplug, in accordance with the present invention.

FIG. 25A-D illustrates a tissue repair system and method that includes aknotless suture in accordance with the present invention.

FIG. 26 illustrates an alternative tissue repair system and methodincluding a mulit-loop suture in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower”, “upper”,“top”, and “bottom”, designate directions in the drawings to whichreference is made. The words “inwardly” or “distally” and “outwardly” or“proximally” refer to directions toward and away from, respectively, thegeometric center of the intervertebral space. The words, “anterior”,“posterior”, “superior”, “inferior”, “lateral” and “medial” and relatedwords and/or phrases designate preferred positions and orientations inthe human body to which reference is made and are not meant to belimiting. The terminology includes the above-listed words, derivativesthereof and words of similar import.

While the tissue repair system and method will be shown and describedwith reference to repairing a defect in the annulus fibrosis of a spinaldisc it should be understood that the tissue repair system and methodwill have applicability to other bodily tissue and applications. Forexample, the tissue repair system and method may be used for meniscalrepair, rotator cuff repair, gastroplication procedures, inguinal herniarepair, dural repair, etc. Moreover, the tissue repair system and methodmay be used for fixation of an implant to soft tissue, such as, forexample, suture fixation of adhesion barriers, hernia meshes, rotatorcuff patches, etc. In addition, while reference is often made to adefect in the annulus fibrosis of a spinal disc, or annulus defect, thetissue repair system and method is not limited in its application toannulus defects but applies to any incision, opening, wound, herniation,damage or defect in the annulus fibrosis of a spinal disc or bodilytissue. The term “annulus defect” or “tissue defect” and words ofsimilar import should be given a broad, as opposed to a limited,interpretation to cover all such applications unless indicatedotherwise.

A tissue repair system and method is provided, preferably an annulusrepair system and method, that preferably includes a suture and a sutureclasp. The suture 20, as shown in FIG. 1 is preferably a loop 21 ofsuture material pre-tied with a knot 25 which, in various embodimentscan include any type of sliding knot, ratcheting knot, or locking knotnow or hereafter known in the art. In a preferred embodiment, the knotis a ratcheting and/or locking knot that prevents post-operativeloosening of the repair construct. The suture preferably includes afirst loop end 22, a second loop end 24, and a free length of suturestrand 26 adjacent to and extending from the knot 25. In thisembodiment, one of the free suture strands 27 is preferably cut adjacentto the knot during manufacture. Alternatively, both free strandsextending from the knot can remain, thus allowing the user to tensionboth strands upon final tissue approximation to promote additionallocking of the knot. While the suture 20 may be supplied to thehospital, operating center or operating room with a pre-formed orpre-tied knot and loop, the suture 20 may also be configured in theoperating room before or during the surgery to include a loop 21, firstloop end 22, second loop end 24, knot 25 and free strand 26.

The clasp 60, in one embodiment as best shown in FIG. 2, is preferably asimple ring 61 of biocompatible material with a slot 62 configured toallow one or more loops of suture material to be secured to the clasp.In one embodiment, the clasp preferably includes a slot 62 that providesthe open ring clasp in a C-shape, while in alternate embodiments, theclasp may include a carabiner-type mechanism or spring-loadedretractable sliding member 63 that enables the clasp to open and secureone or more suture loops and then close to form a closed ringconfiguration. The suture clasp may assume the form of the open ringsuture clasp 61 as shown in FIG. 2, or may assume the form of a closedring suture clasp 65, as best shown in FIG. 3, or may assume the form ofa double eyelet suture clasp 51, as best shown in FIG. 4 and describedin detail below. The suture clasp may also be U-shaped, S-shaped,C-shaped, O-shaped, coil shaped, or any other shape that has an openingto permit the loop end of a suture to pass into and be secured to theclasp.

Referring to FIG. 3, clasp 65 has a closed eyelet loop 66 and twolateral integrated cleats 67, 69. In use, the suture 20, and morespecifically loop end 22, is passed through the opening 68 in the eyeletloop 66, looped over the cleat 69, and cinched tight to attach thesuture loop end 22 to the clasp 65. The other suture loop end 24 ispassed through the opening 68 in the eyelet loop 66, looped over thecleat 67, and cinched tight to attach suture end 24 to the clasp 65.Suture loop 24 may additionally or alternatively be passed over cleat 69holding suture loop 22. Suture clasp 65 may be used with multiplesutures 20, or each suture strand 20 may use a single suture clasp 65.

Referring to FIG. 4, another embodiment of a suture clasp device 51 isprovided. The clasp 51 features two oppositely arranged eyelets 52, 54,wherein each eyelet includes a slot 53 through which each end 22, 24 ofa suture loop 21 can be routed, preferably such that the final sutureloop-clasp construct is a continuous band. The slots 53 can bepermanently or temporarily opened to permit the suture loop end to passwithin the eyelet. Temporary opening of the slot 53 can be accomplishedwith a variety of mechanisms, such as a spring-loaded sliding actuatemember (similar to a jewelry clamp), a spring-loaded hinged flap(similar to a carabiner), or a hingless elastic eyelet that allows theslot 53 to open under load and close thereafter. These same mechanismscan be utilized in clasps 61 or 65. In use the suture loop end 22 may beinserted through slot 53 in eyelet 52 while the suture loop end 24 maybe inserted through slot 53 in eyelet 54 to attach the two ends of thesuture loop to the clasp 51. Suture clasp 51 may be used with multiplesutures 20, or each suture strand 20 may use a single suture clasp 51.

A system and method for repair of a disc annulus using a suture 20 andclasp 60 is illustrated in FIGS. 5A-E. Clasp 60 may be any one of clasps51, 61 and 65 shown and described in FIGS. 2, 3 and 4, or alternativeclasps may also be used. In use, a suture, such as, for example, thesuture 20 illustrated in FIG. 1, is preferably provided that is pre-tiedto include a ratcheting, locking, or other sliding knot 25 such that thesuture includes a first loop end 22, a second loop end 24, and a freelength of suture strand 26 adjacent the knot 25. As shown in FIG. 5A thefirst loop end 22 of the suture is passed through the annulus wall 5into the interior 3 of the disc 1 on a first side of an annulus defect 2while the other end 24 of the suture, including the suture knot 25 andthe free strand 26 of suture, remain external 6 to the annulus wall 5.The first loop end 22 of the suture 20 is then retrieved through theannulus defect 2 and held exterior 6 to the annulus wall as shown inFIG. 5B.

The second loop end 24 of the suture 20 as shown in FIG. 5C is thenpassed through the annulus wall 5 into the interior 3 of the disc 1 on asecond side of the annulus defect 2 while the first loop end 22 of thesuture, the suture knot 25, and the free strand 26 of suture 20 remainexternal 6 to the annulus 5. As shown in FIG. 5D, the second loop end 24of the suture is then retrieved through the annulus defect 2 and heldexterior 6 to the annulus 5 and adjacent the first loop end 22. Theclasp 60 is then used to join the first and second loop ends 22, 24. Thefree strand 26 of suture is then pulled, whereby the clasp 60 and thetwo loop ends 22 are drawn into the interior 3 of the disc and theannulus defect or opening 2 is approximated and closed as shown in FIG.5E. Alternatively, the clasp 60 may be advanced into the interior of thedisc first, then the free strand 26 of suture 20 is pulled toapproximate the annulus defect. The free strand 26 of suture may then betrimmed. The suture can be passed through the body tissue with a needleor other known suture insertion device, or the devices described herein.In the method of FIGS. 5A-E, the suture loop is passed from the outsideor exterior of the disc annulus to the interior of the disc space andthereafter retrieved through the defect so that the suture can beconnected to the clasp while both the clasp and suture are exterior tothe disc space, and preferably exterior to the patient.

Referring to FIG. 4, an inserter 50 is provided that enables a surgeonto advance the clasp 51 manually through an annulus defect. The inserter50 is connected to the clasp, for example, via a threaded interface. Theinserter optionally may be cannulated to accept the suture strand(s) andallow cinching of the construct for tissue approximation. In thetechnique used with inserter 50, the ends 22, 24 of the suture loop 21are passed through the thickness of the annulus wall 5 from outside toinside and the loops 22, 24 are retrieved through the opening 2 in theannulus as described in the method of FIG. 5. With the loop ends 22, 24exterior to the disc space, the loop ends are hooked to the clasp 51 byinserting the loop ends 22, 24 through the slots 53 in the eyelets 52,54. The free end 26 of the suture strand is passed up the cannulatedshaft of the inserter 50. The clasp inserter 50 with connected sutureloops ends 22, 24 is advanced through the defect 2 in the annulus wall 5and the free end 26 of the suture is pulled to cinch up the loop 21 anddraw the ends of the opening in the annulus together. The inserter 50 isdetached from the clasp (e.g., unthreaded) and the free strand 26 of thesuture 20 is cut as desired. Alternatively, the free strand 26 and knot25 may be positioned external to the disc as shown in FIGS. 11, 15, 18,and 17. The inserter 50 can be optionally used in conjunction with themethods shown in FIGS. 5-11, or other methods described herein.

In the tissue repair system and method of FIGS. 5A-E, the clasp is inseries with the suture loops and forms a continuous strand of suture.Without the clasp in FIGS. 5A-E the suture would not approximate andclose the tissue defect. The system and technique of FIGS. 5A-E haveparticular application to a surgical site deep within the body. Thesuture is reapproximated to the clasp and the clasp and suture incombination cinches and reapproximates the defect (i.e. draws the tissuedefect closed). One advantage of the tissue repair system and method isthe use of pre-tied sutures which form a loop as shown in FIG. 1.Pre-tied sutures facilitate the speed and increases the reliability ofthe wound closure since a surgeon will not need to form knots withsuture strand in a surgical environment and deep within a patient. In asurgical environment where (1) the surgeon is working with surgicalgloves, (2) the wound is deep within a patient, (3) the openings to thesurgical site are minimized to facilitate speedy recovery and (4) thesurgical site has blood and other bodily tissue and fluids makingvisibility and manual dexterity difficult, tying and manipulating suturestrands can be difficult, and the use of pre-tied sutures may beadvantageous.

A tissue repair system and method is provided in FIGS. 6-11 that mayhave particular application to repairing a spinal disc annulus, or otherbody tissue, and that preferably includes a suture 20, a suturepasser/retriever instrument 70, and a suture clasp 60. The suture may beas illustrated in FIG. 1, and the clasp 60 may be any one of clasps 51,61 and 65 shown in FIGS. 2-4, or other clasps that connect the ends ofthe suture loop. The suture passer/retriever instrument 70 may beconfigured to allow a suture loop 21 to pass through an annulus wall 5on either side of a defect 2 from the external side 6 of the annuluswall to the interior side 3 of the annulus wall 5. The suturepasser/retriever instrument 70 may also be configured to retrieve thepassed suture loop end 22 from within the interior of the disc to enablea surgeon to secure the suture loop 21 to a clasp 60 located external tothe disc space 3. In alternate embodiments discussed in more detailbelow, the clasp can be loaded into or onto the suture passer/retrieverinstrument such that the suture loop 21 can be passed through theannulus wall to the interior of the disc space and captured directly bythe clasp while within the interior of the disc space.

The suture passer/retriever instrument 70 includes a frame or housing 75which further includes a proximal portion 72 (not shown), a distalportion 74 and a longitudinal axis 71 extending therebetween. Theproximal portion of the suture passer/retriever instrument 70 includes acannulated portion 76 configured to house and direct the movement of aneedle 80. The needle 80 has an open slot (see FIG. 20) through which ispassed a strand of the suture 20. The distal portion 74 of the suturepasser/retriever instrument 70 is configured for placement through thedisc annulus defect and into the interior 3 of the disc space. Thedistal portion 74 may be characterized by a thin portion 78 that issized and configured for introduction through an annulus defect and alaterally extending boom arm 77. The boom arm 77 may also include adistally extending obliquely oriented tip 79, as is best shown in FIG.6, that is sized and configured to retrieve the suture once inside thedisc space. The boom arm 77 may include a latch or hook that would catchand retain the suture loop as the needle is withdrawn from the discannulus. The suture passer/retriever instrument 70 is unidirectional inthat the suture only passes in one direction through the disc annulus.

In use, and with reference to FIGS. 6-11, the first end 22 of the sutureloop 21 is preferably secured to the needle 80 seated within the frame75 of the suture passer/retriever device 70 and the distal end 74 of thesuture passer/retriever device 70 is inserted into the interior 3 of thedisc space through a defect 2 within the wall 5 of the annulus, as bestshown in FIG. 6. The needle 80 carrying the first end 22 of the sutureloop 21 then moves through the annulus wall 5 on one side of the defectwhile the second end 24 of the suture loop 21, knot 25, and free strand26 of the suture are retained outside of the disc space, as best shownin FIG. 7. The needle 80 is then retracted back into the housing 75 ofthe suture passer/retriever device 70 while, the first end 22 of thesuture loop 21 is captured by the boom arm 77. The suturepasser/retriever device 70 (with the suture loop 21 captured by the boomarm) then is withdrawn from the disc space 3 through the annular defect2, as best shown in FIG. 8. The first end 22 of the suture loop 21 isthen removed from the suture passer/retriever instrument 70 and is heldoutside of the disc space.

The second end 24 of the suture loop 21 is secured to the needle 80 andthe distal end 74 of the suture passer/retriever device 70 is reinsertedinto the interior 3 of the disc space through the annulus defect. Thesuture passer/retriever instrument 70 is manipulated so that the boomarm 77 is located beneath the other side of the annulus defect where theuser desires to pass the suture. The needle 80 carrying the second end24 of the suture loop 21 then translates distally and is guided throughthe annulus wall 5 on the other side of the annulus defect 2 while thefirst end of the suture loop 22, knot 25, and free strand 76 of sutureare retained outside of the disc space, as best shown in FIG. 9. As bestshown in FIG. 10, the needle 80 is withdrawn proximally back towards thehousing 75 of the suture passer/retriever device 70 and, the second end24 of the suture loop is captured by the boom arm 77. The suturepasser/retriever device 70 with the captured suture loop end 24 then iswithdrawn from the disc space through the annulus opening. A sutureclasp 60, such as either of the suture clasps 51, 61, 65 shown anddescribed in reference to FIGS. 2-4, or other clasp type is used to jointhe first and second ends 22, 24 of the suture loop 21. The free strand26 of the suture is then pulled, which can in one example be facilitatedby using a knot pusher known in the art for use with sliding sutureknots, whereby the suture clasp 60 and the two loop ends 22, 24 aredrawn into the interior 3 of the disc 1 and the annulus defect 2 isapproximated, as is best shown in FIG. 11.

Alternatively, the clasp 60 and loop ends 22, 24 may be advanced intothe interior 3 of the disc first, and then the free strand 26 of sutureis pulled to approximate the annulus defect. The free strand 26 ofsuture is then trimmed, while the knot 25 is exterior to the annulus.Alternatively, or additionally, the knot may be fully recessed byadvancing it into the annulus, for example, down one of the needletracts during cinching.

In the system and method of FIGS. 6-11, the suture loop is passed fromthe outside of the disc annulus into the interior of the disc space andthereafter retrieved through the disc annulus defect so that the suturecan be connected to the clasp while both the clasp and ends of thesuture loop are exterior to the disc space, and preferably exterior tothe patient so that the suture can be easily handled and connected tothe clasp. In the tissue repair system and method of FIGS. 6-11, theclasp is in series with the suture loop and forms a continuous strand ofsuture. The suture loop is connected to the clasp, and the suture incombination with the clasp cinches and reapproximates the tissue defect.Without the clasp in the method of FIGS. 6-11, the suture would notreapproximate the tissue defect.

Referring to FIGS. 12-15, a tissue repair system and method is providedthat preferably includes a suture loop 21 with pre-tied knot 25 asdescribed previously, a suture passer/retriever instrument 70, andsuture clasp 60 preloaded onto the suture passer/retriever instrument,thereby saving procedural effort and time. The clasp 60 may be threadedonto, snap fit, or connected to the boom arm 77 by other methods.Preferably the clasp 60 is configured similar to the open ring clasp 61in FIG. 2. The method of operation of FIGS. 12-15 is similar to thatdescribed above in connection with FIGS. 6-11. During the step shown inFIG. 13, however, as the needle translates and is guided downwardlythrough the annulus wall on one side of the annulus defect, the firstend 22 of the suture loop is hooked through the preloaded open ringsuture clasp 61 secured to or within the boom arm 77. Similarly, andwith reference to FIG. 14, as the needle translates and is guideddownwardly through the annulus wall on the opposite side of the annulusdefect, the second end 24 of the suture loop is hooked through thepreloaded open ring suture clasp 61 secured to or within the boom arm77. During the last step, and with reference to FIG. 15, the preloadedopen ring suture clasp 60 is manually or automatically ejected from thesuture passer/retriever instrument 70, the distal end 74 of the suturepasser/retriever instrument 70 is removed from within the disc, the freestrand of suture 26 is pulled, the sutures are cinched and drawn tightto close the annulus defect, and the free strand 26 of suture istrimmed. In the embodiment and method described in FIGS. 12-15 the claspand instrument 70 remain within the annulus until both ends of thesuture loop are connected to the clasp and then the instrument 70 isremoved from the disc. The clasp in the embodiment and method of FIGS.12-15 preferably remains inside the disc. A rod (not shown) may beoperated by the user to push or eject the clasp from the instrument 70.

In the embodiment of FIGS. 12-15 the slots in the open ring clasp may beopen when the clasp is attached to the suture passer/retrieverinstrument 70, and the suture passer/retriever instrument 70 may openthe slots as the clasp 60 is attached to the instrument 70. Similarlythe slots may close as the clasp is ejected from the suture/passerretriever instrument 70. That is, the clasp 60 may be configured so thatthe slots are biased or automatically closed unless held open and thesuture passer/retriever instrument 70 may have a mechanism that opensand holds open the slots as the clasp is loaded onto the instrument 70.When the clasp is released from the instrument 70 the slots willautomatically close.

While the suture passer/retriever instrument 70 shown and described inFIGS. 6-11, and 12-15 has been configured to have the needle associatedwith retaining and moving the suture from the exterior to the interiorof the disc other configurations are contemplated. For example, thesuture may be retained on the boom arm 77 of the suture passer/retrieverinstrument and the needle may pass from the exterior to the interior ofthe disc and as the needle is being withdrawn from the disc it willcapture the suture loop and pull it back out through the annulus wall.The same method may apply to the other end of the suture loop and withboth suture loop ends outside of the disc a clasp may thereafter beconnected to the suture loop ends and the suture cinched and tightenedto close the annulus opening in combination with the clasp.

Referring to FIGS. 16 and 17, an annulus repair system and method isprovided that includes a suture loop 21 with knot 25, a suture clasp 60similar or identical to the suture clasp 51 shown and discussed inreference to FIG. 4, and a pair of barbs 90. The suture clasp 60, suture20, and suture barbs 90 are best shown in FIG. 17. The suture clasp 60is preloaded onto the suture passer/retriever instrument 70, and themethod is similar to that described above in reference to FIGS. 12-15.

The suture barbs 90 preferably have a stem 96 with an eyelet 97 forcapturing one end of the suture loop. The barb 90 also preferably has atip, preferably pointed for piercing and passing through the discannulus. One of the suture barbs 92 may be connected to the first end 22of the suture loop 21 and the second suture barb 94 may be connected tothe second end 24 of the suture loop 21. The suture and barbs may besupplied preassembled and connected together and in a kit, or the sutureconnections with the barbs may occur before or during the procedure.With preassembled barbs where the suture loop is connected to the barbthe surgeon does not have to tie knots to close the disc annulus openingpotentially resulting in a faster procedure and a more reliable closureof the annulus opening. The barb may be mounted to a suture passerinstrument 70 similar to the embodiments of FIG. 5-11 or 6-12 butadapted to utilize barbs 90 instead of a needle in use.

The barb 90 is moved through the disc annulus and the tip 98 of the barb90 moves through eyelet 54 until the stem 96 of the barb is locatedwithin the eyelet. More specifically, the proximal end of the tip 98 islarger than the eyelets 52, 54 so that as tip 98 moves through theeyelet 52, 54 the eyelet as a result of slots 53 expands to a largersize to enable the tip 98 to pass through eyelet 52, 54 whereupon thestem 96 is received in the eyelet 52, 54 and the eyelet returns to itsoriginal unflexed state. The barb 90 is thereby captured by the clasp60. The second barb 90 is inserted through the annulus of the disc at asecond location and the tip 94 is passed through the eyelet 54 until thestem 96 is located within the eyelet 54. The clasp 60 is thereafterejected from the suture passer/retriever instrument as shown in FIG.17A. The suture loop is then tightened by pulling free strand 26 whichcinches the sutures, proximating and closing the annulus defect as shownin FIG. 17B.

Depending upon the design of the barbs 90 it may or may not be desirablefor the stems 96 of the barbs 90 to extend up and into the wall of theannulus. If it is undesirable for the stems of the barbs to be locatedwithin the punctures formed by the barbs upon proximating and closingthe opening in the annulus, which may be desirable and necessary toachieve proper reapproximation of the defect, then care should be taken,for example, by insuring that the distance between the punctures in theannulus when the defect in the annulus is closed is greater than thedistance of the eyelets in the clasp.

Referring to FIG. 18, an alternate embodiment of a suture passinginstrument is provided. The suture passer 30 of FIG. 21 includes anaxially translatable suture passing needle 31 moveable within a needlehousing 35 by a needle knob 36. The needle housing 35 is attached to aguide body 32. The guide body 32 has a handle 37 and also includes alumen 34 that houses a deployable wire loop 33 configured to snare andretrieve a suture 20 passed through the annulus. The guide body 32 andlumen 34 may be angled at its distal end, preferably towards theprojected path of the needle. The suture passer has a knob 38 forcontrolling movement of the wire loop 33 which is deployed from thedistal end of the guide body 32 in such a way that it encircles or ismoveable to encircle the projected path of the needle 31 and/or thepassed suture to allow the passed suture to be retrieved using a “blind”technique that does not require direct visualization.

The needle 31 can be loaded with the suture loop 21. The distal end ofthe suture passer 30 including the angled lumen of the guide body andthe wire loop 33 are inserted through the opening 2 in the annulus to berepaired and the wire loop 33 is manipulated so that it encircles theprojected path of needle 31. The needle 31 is advanced through theannulus wall and through the wire loop and the wire loop is used tocatch the suture 20. The needle 31 is retracted while the wire loop 33holds the suture 20. The suture passer 30 is then removed from theannulus with the wire loop holding and retrieving the suture from insidethe disc so that the suture passes out of the annulus opening. The sametechnique is employed with the suture passer 30 in other location(s)surrounding the annulus opening and the suture is retrieved from theinterior of the disc space through the opening. The suture ends are thenconnected to a clasp 60, which can be any one of the clasps 51, 61, 65shown in FIGS. 2-4, or any other clasp, and the method of cinching thesutures and closing the opening of the annulus as described and shown inFIGS. 5D-E, 11 and 15 can be employed. The guide body 32 mayalternatively accommodate multiple needles or needle housings arrangedabout its outer diameter and corresponding deployable wire loops or asingle rotationally-indexing wire loop. In one embodiment, the needlemay be straight and the lumen may be angled, the lumen projectingtowards the opening of the axially deployed wire loop. In anotherembodiment, the suture passing needle 31 may be curved at its distal endwith the wire loop 33 deploying axially.

FIGS. 19A-F illustrates another embodiment of a tissue repair system andmethod. The tissue repair system of FIGS. 19A-F includes a suture 20,and a two-piece connector clip 35. The two piece connector clip 35includes a first clip part 36, having a projecting portion 37, and asecond clip part 38 having a receiving portion 39. The first clip part36 attaches to the second clip part 38. The clip parts 36, 38 may beconnected in many ways now known or hereafter developed includingthreaded connections, snap connections, interlocking flanges andshoulders, etc. Each clip part 36, 38 may further include a channel,hole or eyelet so that the suture can be attached to the clips parts 36,38.

The suture 20 and two piece connector clip parts 36, 38 may be providedpreassembled for the surgery where a first loop end 22 is associatedwith and preferably connected to the first clip part 36, and the secondloop end 24 is associated with and preferably connected to the secondclip part 38 forming a suture loop 21 with a pre-tied knot 25 and freelength of suture strand 26. A needle (not shown) is inserted through theannulus wall 5 and the first part 36 of the clip connector 35 is passedthrough the annulus into the interior of the disc as shown in FIG. 19A.The suture 20 is free to slide through the hole in the first clip part36. The first clip part 36 is retrieved through the defect in theannulus wall so that it is outside or exterior to the disc space asshown in FIG. 19B. Next the needle is inserted through the other side ofthe defect in the annulus and the second clip part 38 is passed throughthe annulus 5 as shown in FIG. 19C so that it is located in the interiorof the disc. The second clip part 38 is then retrieved through thedefect in the annulus so that it is outside or exterior to the discspace as shown in FIG. 19D. The two clip parts 36, 38 are clippedtogether preferably while located exterior to the disc space as shown inFIG. 19E, and preferably exterior of the patient, and the suture knot 25is pulled tight so the clip 35 is drawn into the disc space as shown inFIG. 19F, and the two sides of the annulus defect are drawn tightlytogether. Several suture and clip assemblies 35 may be used together torepair the tear, defect, incision, or opening in the annulus of thespinal disc.

In the system and method of FIGS. 19A-E the suture loop is passed fromthe outside of the disc annulus into the interior of the disc space andthereafter retrieved through the disc annulus so that the clips can beconnected while both the clips and ends of the suture loop are exteriorto the disc space, and preferably exterior to the patient so that thesuture can be easily handled and the clips connected together. In thetissue repair system and method of FIGS. 19A-F, the clips are in serieswith the suture loop and forms a continuous construct. The suture isconnected to the clips, and the suture in combination with the clipscinches and reapproximates the tissue defect. Without the clips in themethod of FIGS. 6-11, the suture would not approximate and draw thetissue defect closed.

A further embodiment of a suture based tissue repair system and methodis shown in FIGS. 20-22. The suture based tissue repair system of FIG.20 includes a needle 81 configured and adapted to hold and connect to asuture 20, a clasp 60 and a clasp inserter 45. The needle 81 may beindependent of the clasp 20 and clasp inserter 45 or may be part of anintegrated design as illustrated and described with reference to FIG.21. The needle has an opening or notch 82 in its distal end and achannel 83 for guiding and maintaining the suture across the needleopening. A further channel 84 may be provided to retain the suture alongthe length of the needle. The guide channel 83, opening 82 and clasp 60are configured so that the suture 20 can be inserted through the slot inthe clasp 60 and looped over the open end of the clasp 60.

FIG. 21 illustrates an alternative suture assembly and clasp instrument110. The suture inserter and clasp assembly instrument 110 has a firstneedle 112 and a second needle 114 located within and slidable relativeto housing 115. Housing 115 is cannulated and has an inserter 120located within cannulated bore 116. The inserter 120 is moveablerelative to the housing 115 and preferably slidable within bore 116 inhousing 115. A clasp 60, similar to clasp 60 in FIG. 20, is connected tothe distal end of the inserter 120. First needle 112 and second needle114 each may be structured and configured similar to needle 81 in FIG.20. A suture 20 is threaded across an opening in the first and secondneedles 112, 114 similar to FIG. 20. The first and second needles 112,114 each have a handle 118 that extends through a slot located inhousing 115 and are each independently operable by a user to move eachrespective needle relative to the housing so the distal end of theneedle extends from the housing. A first loop end 22 of the suture 20extends around the first needle 112 and a second loop end 24 of thesuture 20 extends around the second needle 114. The suture knot 25preferably is located within the housing and the free strand 26 of thesuture extends out the bore 116 of the housing 115.

The use of the needle 81 and the clasp inserter 45 of FIG. 20, and theuse of the suture inserter and clasp assembly instrument 110 of FIG. 21,is shown in FIGS. 22A-K. The inserter 45, 110 and clasp 60 is insertedthrough the defect in the annulus of a spinal disc. If the assembly 110of FIG. 21 is used, the tip of the cannula 119, which houses theinserter 120 and clasp 60 assembly, is inserted through the annulusdefect as shown in FIG. 22A and the inserter 120 is then moved inhousing 115 so the clasp 60 extends outside the cannula 119 and into theinterior of the disc space as shown in FIG. 22B. The clasp 60 preferablyexpands to a larger or different size as it exits the cannula 119 asshown in FIG. 22B. The inserter/clasp assembly may be moved toward thefirst side of the annulus as shown in FIG. 22C and the needle 81, orfirst needle 112 may be inserted through the annulus. Next the sutureend 22 is looped over the clasp as shown in FIG. 22D and the needle 81,112 is withdrawn from the annulus with the first loop end 22 of thesuture wrapped around the clasp 60 as shown in FIG. 22E. Theinserter/clasp assembly instrument 110 is moved to the other side of theannulus defect, shown in FIG. 22F, and the needle 81, second needle 114is inserted through the second side of the annulus, shown in FIG. 22G,and the needle is moved over the clasp 60 so that the suture is hookedonto and held by the clasp as shown in FIG. 22H. The needle 81, secondneedle 114 is withdrawn from the annulus with the suture held by theclasp 60 as shown in FIG. 22I. The inserter 45, 120 is then disconnectedfrom the clasp 60, shown in FIG. 22J, and the inserter is withdrawn fromthe annulus defect. The suture 20 is then drawn tight so that theopening in the annulus is closed and drawn tightly together and the freeend of the suture is cut as desired.

The systems and methods described above can be further adapted for usewith more than one suture loop, as shown in FIG. 23. In this embodiment,the ends of each suture loop could be secured by the same clasp, oroptionally a separate clasp could be used for each suture loop. Thesuture loops could be passed through the annulus and around the annulardefect in configurations known in the prior art or hereafter discovered.Examples of these configurations, which are commonly used in clinicalpractice, would be a cruciate configuration (shown) or a stackedmattress configuration.

Additionally, or alternatively, the systems and methods described abovemay utilize two suture loops (each with its own sliding knot and freestrand) on the same strand of suture. For example, referring to FIG. 26a suture based tissue repair system and method is disclosed whichincludes a multi-loop suture 20 and a suture clasp 60. In FIG. 26 onlytwo loops 21, 21′ are illustrated but more than two loops may bepossible. The loops 21, 21′, 21″, etc. may be pre-tied with one or moreknots 25, 25′, 25″, etc. which, in various embodiments can include anytype of sliding knot, ratcheting knot, or locking knot now or hereafterknown in the art. In a preferred embodiment, the knots are a ratchetingand/or locking knot that prevents post-operative loosening of the repairconstruct. Each suture loop 21, 21′, 21″, etc. preferably includes afirst loop end 22, 22′, 22″, etc., a second loop end 24, 24′ 24″, etc.,and a free length of suture strand 26, 26′, 26″, etc. adjacent to andextending from the knot 25, 25′, 25″, etc. In this embodiment, the freesuture strand 27 adjacent the knot 25 extends to the adjacent knot 25′.The clasp 60 in FIG. 26 may be any one of the clasps, or clips describedor illustrated herein, or additional or alternative clasps or clips. Themulti-loop suture may be utilized as described in the methods herein,and preferably the suture loops and the clasp or clip in combinationwork in series to close the tissue gap and reapproximate the tissue.While the multi-loop suture 20 may be supplied to the hospital,operating center or operating room with a pre-formed or pre-tied knotand multiple loops 21, 21′, 21″, etc., the suture 20 may also beconfigured in the operating room before or during the surgery to includeloops 21, 21′; first loop ends 22, 22′; second loop ends 24, 24′; knots25, 25′ and free strands 26, 26′.

Referring to FIG. 24, an alternate system and method similar to thatshown and described when referring to FIG. 4 is shown. The system andmethod of FIG. 24 includes the clasp 51 of FIG. 4 and further includes aplug 55 for occluding the annular defect, which is well suited forcircumstances in which the annular defect is too large to allow adequatereapproximation using only the sutures and clasps described above. Theplug 55 preferably is formed of a compliant biocompatible material, suchas collagen, cellulose, hydrogels, etc., and may serve as a scaffold tofacilitate healing. The plug 55 is connected to clasp construct 60, andthe plug 55 can be attached to the clasp 60 via direct means, such asadhesive, or may be attached using connecting bands or sutures or anyadditional means. In use, the plug is positioned in the annulus defectand encircled by the suture loop and clasp. The plug/clasp assembly canbe implanted and used as described in connection with FIGS. 4 and 5A-E,where the suture loop ends are connected to the clasp while outside ofthe disc space as shown in FIG. 24A and then the plug/clasp assembly isdrawn into the annulus defect with the plug preferably remaining atleast partially within the annulus opening as shown in FIG. 24B.

Alternatively, the plug can include a suture-locking mechanism thateliminates the need for a suture loop with a pre-tied knot. In such anembodiment, one strand of suture is passed through a full-thicknessstitch encircling the annulus defect and the free strands of the sutureare routed through the suture-locking mechanism within the defect orwithin the disc space. The suture-locking mechanism can be, for example,a locking dowel within an outer cylindrical sheath as described below inconnection with FIG. 25. The suture-locking mechanism can optionally besurrounded by a biomaterial to provide a scaffold and fill the annulusdefect. The suture-locking mechanism can optionally be located withinthe disc (i.e. not within the annulus defect).

Referring to FIG. 25, an annulus repair system and method is providedthat includes a suture 20, a locking anchor 85, and an inserterinstrument 40 that further includes an inserter shaft 42 and atrigger-activated plunger 44. The locking anchor 85 further includes alocking sheath 46 and a locking dowel 48. The locking anchor may bepre-loaded onto the inserter instrument. Using a suture passer andretriever instrument similar to that previously described, a continuousstrand of suture is passed through the annulus such that its free endsare retrieved through the defect, similar in configuration to FIG. 10,with the exception that a single strand of suture is passed, rather thana suture loop with a pre-tied sliding knot. The free ends of the sutureare then threaded through the locking sheath of the locking anchor,which is loaded onto the inserter instrument. The locking anchor 85 andinserter instrument 40 are then passed into or through the annulusdefect, the free strands are tensioned to reapproximate the annulardefect, and the trigger-activated plunger 44 is advanced to allow thelocking dowel 48 to engage the locking sheath 46, thereby locking thefree strands of suture 20 within the locking anchor 85. The insertertool 50 is then disengaged from the locking anchor 85, and the freestrands of suture are cut.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, andfeatures and structures may be used singularly or in combination, and itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the appended claims.

We claim:
 1. A system configured to approximate bodily tissue, thesystem comprising: a strand of suture having at least one loop, at leastone knot that closes the at least one loop, and a free length of suturethat extends from the at least one knot, the at least one loop defininga first closed loop end and a second closed loop end; and a clasp devicehaving: first and second side surfaces that are spaced from one anotheralong a first direction by a first dimension; first and second opposedend surfaces that extend between the first and second side surfaces, andthat are spaced from one another along a second direction, perpendicularto the first direction; upper and lower surfaces that extend between thefirst and second side surfaces and between the first and second opposedend surfaces; and a central body portion having a free end thatterminates at a third side surface, and having a pair of internal endsurfaces that are spaced from one another along the second direction andthat extend from the third side surface towards the second side surface,the second and third side surfaces facing away from one another andspaced from one another along the first direction by a second dimensionthat is no greater than the first dimension, the clasp device defining afirst eyelet that extends from the upper surface to the lower surfaceand between the central body portion and the first end surface, a firstslot open to both the first eyelet and the first side surface, a secondeyelet that extends from the upper surface to the lower surface andbetween the central body portion and the second end surface, and asecond slot open to both the second eyelet and the first side surface,the clasp device including, for each of the first and second eyelets,first and second interior surfaces that at least partially define therespective first and second eyelets, each second interior surface spacedbetween the second side surface and a respective one of the firstinterior surfaces along the first direction such that the central bodyportion extends from the third side surface past the second interiorsurfaces to the second side surface along the first direction, the claspdevice defining an overall dimension from the first end surface to thesecond end surface along the second direction, and a maximum dimensionfrom the second side surface to one of the second interior surfacesalong the first direction, the maximum dimension being less than theoverall dimension, wherein the clasp device is configured to join thefirst closed loop end and the second closed loop end by passing thefirst closed loop end through the first slot and into the first eyeletand the second closed loop end through the second slot and into thesecond eyelet such that when the free length of suture is pulled, thebodily tissue is approximated.
 2. The system of claim 1 wherein thefirst eyelet and the second eyelet are configured such that the firstclosed loop end and the second closed loop end extend in oppositelateral directions from the clasp.
 3. The system of claim 1 furthercomprising a suture passer and retriever instrument.
 4. The system ofclaim 1, wherein the clasp device and strand of suture are configuredand sized to repair a defect in an annulus of a spinal disc.
 5. Thesystem of claim 1, wherein the maximum dimension is less than adimension from one of the second interior surfaces to the first sidesurface.
 6. The system of claim 5, wherein the clasp device defines asecond maximum dimension from the first side surface to one of the firstinterior surfaces, the second maximum dimension being less than thedimension from the one of the second interior surfaces to the first sidesurface.
 7. The system of claim 1, wherein the central portion extendsfrom the second side surface past the second interior surfaces to thethird surface along the first direction.
 8. The system of claim 1,wherein the pair of end surfaces extend from the third side surface tothe second interior surfaces.
 9. A system configured to approximate asoft tissue defect, the system comprising: a strand of suture thatdefines at least one loop having two closed ends, the strand of sutureincluding a sliding, locking, or ratcheting knot, and a free end thatextends from the knot; and a clasp device having: first and second sidesurfaces spaced from one another along a first direction; first andsecond opposed ends that extend between the first and second sidesurfaces; upper and lower surfaces that extend between the first andsecond side surfaces and between the first and second opposed ends; acentral body portion having a free end that terminates at a third sidesurface that faces the first direction, and a pair of end surfaces thatare spaced from one another along a second direction, perpendicular tothe first direction, the pair of end surfaces extending from the thirdside surface towards the second side surface along the first direction,and the central body portion extending from the second side surface tothe third side surface along the first direction without extendingbeyond the first side surface such that the central body portion has alength from the second side surface to the third side surface along thefirst direction, a first arm that extends from the central body portiontoward the first end along the second direction; and a second arm thatextends from the central body portion toward the second end in adirection that is away from the first arm and opposite the seconddirection, wherein each arm at least partially defines an opening thatextends from the upper surface to the lower surface, each opening isopen to the first side surface, the second side surface is devoid ofopenings at the upper surface, and the length of the central bodyportion is greater than a greatest dimension of each of the openingsalong the first direction, wherein the clasp device is configured tosecure the two closed ends of the loop by routing each closed end into adifferent one of the openings, and wherein the strand of suture andclasp device are configured in combination to surround the soft tissuedefect and at least partially approximate the soft tissue defect. 10.The system of claim 9 wherein the strand of suture and clasp device areconfigured to be in series so as to form a second loop, different fromthe first loop, the second loop surrounding the soft tissue defect. 11.The system of claim 9 further comprising a needle configured toreleasably attach to the strand of suture and configured to pass thestrand of suture through the soft tissue.
 12. The system of claim 11further comprising a suture passer and retriever instrument, the suturepasser and retriever instrument is configured to cooperate with theneedle.
 13. The system of claim 12 wherein the suture passer andretriever instrument comprises a boom arm configured to capture thestrand of suture.
 14. The system of claim 13 wherein the suture passerand retriever instrument is releasably coupleable to the clasp device.15. The system of claim 12 wherein the suture passer and retrieverinstrument comprises a wire loop configured to capture the strand ofsuture.
 16. The system of claim 12 wherein the suture passer andretriever instrument further comprises two needles, each needleconnectable to an end of the strand of suture and being independentlymoveable, the clasp device being releasably connectable to the suturepasser and retriever instrument, the clasp device having an opening forreceiving the strand of suture.
 17. The system of claim 9 furthercomprising a plug member configured to fill and seal the soft tissuedefect.
 18. The system of claim 9, wherein each arm has an interiorsurface that at least partially defines a respective one of theopenings, and an outer surface opposite the interior surface, andwherein the central body portion extends from the interior surfaces tothe third side surface along the first direction.
 19. The system ofclaim 18, wherein the pair of end surfaces extends from the interiorsurfaces to the third side surface.